Our analytical development services encompass the following activities:
Raw material characterization studies
- Solubility studies in different media (organic, aqueous and different pH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization.
- Raw material standardization.
- Forced degradation studies (“stress testing”) of active substances.
- Development of analytical methods for the API (richness, degradation products and residual solvents).
- ICH stability studies for API.
Development and validation of analytical methods of finished products
- Assay method, uniformity of content and preservatives (by spectrophotometry, chromatography and potentiometry).
- Related substances method (liquid, gas or ion chromatography).
- Water content determination method.
- Residual solvent method.
- Dissolution method by UV and HPLC/UPLC.
- Method for active substance determination in “in vitro” permeation studies.
- Enantiomeric purity methods.
- Analysis of trace elements in surfaces (machines cleaning).
- Analytical method transfer.
Analytical support for the formulation development
- Search for discriminative dissolution media.
- Profiles analytics and chemical pre-stability by HPLC.
Finished product characterization studies
- Full analytical characterization of products selected as a reference product.
Comparative in vitro dissolution tests
- Comparative studies of dissolution profiles versus the reference product in ICH media.
Manufacturing process and cleaning control
- Validation and control of cleaning methods and manufacturing process.